OVACEPLUS PLUS- sulfacetamide sodium cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)

Available from:

Mission Pharmacal Company

INN (International Name):

SULFACETAMIDE SODIUM

Composition:

SULFACETAMIDE SODIUM 100 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

Product summary:

This product is supplied in the following size(s): 2 oz. (57 g) bottles, NDC 0178-0495-02 To report a serious adverse event or obtain product information, call 1-800-298-1087. Manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX 78230 1355 R0222

Authorization status:

unapproved drug other

Summary of Product characteristics

OVACEPLUS PLUS- SULFACETAMIDE SODIUM CREAM
MISSION PHARMACAL COMPANY
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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OVACE PLUS (SODIUM SULFACETAMIDE 10%) CREAM
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram contains 100 mg of sodium sulfacetamide in a vehicle
consisting of: benzyl
alcohol, cetearyl alcohol (and) PEG-3 distearoylamidoethylmonium
methosulfate (and)
polysorbate 60, cetyl alcohol, disodium EDTA, fragrance, glyceryl
stearate (and) PEG-
100 stearate, magnesium aluminum silicate, PEG-150 distearate,
phenoxyethanol,
polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium
thiosulfate, stearyl
alcohol and xanthan gum.
Sodium sulfacetamide is a sulfonamide with antibacterial activity.
Sodium sulfacetamide is
C
H
N
NaO
S·H
O with molecular weight of 254.24. Chemically, sodium
sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium
salt,
monohydrate. The structural formula is:
Sodium sulfacetamide is an odorless, white, crystalline powder with a
bitter taste. It is
freely soluble in water, sparingly soluble in alcohol, while
practically insoluble in benzene,
in chloroform and in ether.
CLINICAL PHARMACOLOGY:
Sodium sulfacetamide exerts a bacteriostatic effect against
sulfonamide sensitive Gram-
positive and Gram-negative microorganisms commonly isolated from
secondary
cutaneous pyogenic infections. It acts by restricting the synthesis of
folic acid required
by bacteria for growth, by its competition with para-aminobenzoic
acid. There is no
clinical data available on the degree and rate of systemic absorption
of this product
when applied to the skin or scalp. However, significant absorption of
sodium
sulfacetamide through the skin has been reported.
The following in vitro data is available but the clinical significance
is unknown. Organisms
that show susceptibility to sodium sulfacetamide are: Streptoco